This invention relates to the field of pathologies of the mucosal membranes of the head and facial sinus cavities caused by inflammation.
Introduction
The sinuses are air pockets located inside the bones in the skull. They are located to either side of the nose (maxillary), behind and in between the eyes (ethmoid), in the forehead (frontal), and there is one much further back in the head (sphenoid). Each sinus is drained by a small hole, about 4 mm in diameter, called an ostium. The sinuses are lined with very fine hair-like projections called cilia. The function of the cilia is to encourage the drainage of mucus.
Sinusitis is frequently caused by an obstructed ostium. This obstruction may result from an anatomical defect such as a deviated septum, inflammation due to an upper respiratory infection or an allergic response, drying of the mucus, or a foreign body caused from an accident. When this occurs, mucus that normally is expelled from the sinus builds up in the sinus causing pain, pressure and an excellent culture medium for bacteria. If the mucus is not cleared immediately, an abscess can develop in the sinus. Unfortunately, draining the abscess is not feasible without doing extensive surgery.
Bacterial Sinusitis
Sinusitis is one of the most common medical problems affecting approximately 30% of the population at some point. The most common pathogens associated with acute sinusitis are Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. 
Many strains of both H. influenzae and M. catarrhalis now are beta-lactamase-producing and therefore not susceptible to beta-lactamase antibiotics. Accordingly, broad spectrum antibiotics such as amoxicillin/clavulanate potassium cefuroxime axetil, cefpodoxime proxetil, clarithromycin, and azithromycin are often employed.
The use of decongestants in sinusitis is somewhat controversial. Some authorities to feel that these agents can help to remove the offending matter from the sinus cavities, permitting greater effectiveness for antimicrobial treatment. Others, however, believe that decongestants have no proven role in acute sinusitis and should be avoided because they have side effects and add to the overall cost of treatment. These experts also feel that complicating the therapeutic regimen by having the patient take a decongestant is likely to decrease the likelihood of compliance with the antibiotic treatment.
Chronic sinusitis is defined as sinusitis persisting for at least three weeks. Typically, early in the development of a sinus infection, the cilia are lost and the mucus becomes increasingly thick.
Whereas acute sinusitis is a bacterial infection usually relating to prior viral respiratory tract infection, persistent or chronic sinusitis appears to have a noninfectious etymology. Antimicrobial treatment may clear the condition temporarily, but failure to address and successfully resolve the underlying problem ensures that sinusitis will recur.
A number of conditions can predispose a person to chronic or recurrent sinusitis, including principally, allergic rhinitis. The presentation of chronic sinusitis may be quite subtle, consisting only of congestion, cough, and postnasal drainage; a high index of suspicion is important in identifying possible predisposing factors. The nasal discharge associated with allergic rhinitis is typically clear and watery, and the patient may have symptoms that include itching of the nose and/or eyes.
Among the less common but nonetheless worrisome causes of persistent sinusitis are mechanical obstructions such as polyps or foreign bodies, or mucosal inflammation resulting from disorders such as immunoglobulin deficiencies, cystic fibrosis, and trauma.
Mild cases of chronic sinusitis are usually treated with a regimen of antihistamines/decongestants and/or corticosteroids. Antihistamines may include pseudoephidrine, phenylephrine, phenylpropanolamine, chloropheniramine, bromopheniramine, pheniramine and loratidine. Steroid nasal sprays are commonly used to reduce inflammation in chronic sinusitis. Although these nasal sprays are occasionally used for long-term treatment for patients with chronic sinusitis, the long-term safety of these medications, especially in children, is not fully understood, and the benefits and risks need to be balanced. For patients with severe chronic sinusitis, a doctor may prescribe oral steroids, such as prednisone. Other suitable corticosteroids include betamethasone, cortisone, dexamethasone, hydrocortisone, methylprednisone, and triamcinolone. Because oral steroids can have significant side effects, they are prescribed only when other medications have not been effective. Similar complications exist for antihistamines. Since vascularization of the sinuses is poor, it is difficult to achieve pharmacologically effective concentrations of drugs. As a consequence sinusitis sufferers are often put on lengthy treatments at high dosage, often prescribed in dosages exceeding 2 g per day, from at minimum 2 weeks often extending up to six or eight weeks.
When drug therapies fail to treat the sinusitis, irrigation of saline or saline in combination with antibiotics/antiinflammatories may be applied to treat sinusities of the sinuses immediately downstream from the relevant ostiums passage. If irrigation is ineffective, surgery is often necessary to manually clear the obstructed sinus passages.
Fungal Sinusitis
Research from the Mayo clinic has suggested that sinusitis, especially, chronic sinusitis may have a fungal component to its causation.
Fungal growth was found in washings from the sinuses in 96% of patients with chronic sinusitis. Normal controls had almost as much growth, the difference being that those patients with chronic sinusitis had eosinophiles which had become activated. As a result of the activation, the eosinophiles released Major Basic Protein (MJP) into the mucus, which attacks and kills the fungus but may cause inflammation to the underlying epithelium.
Fungal sinusitis is broken down into several categories: Allergic, Fungus balls (Mycetoma), and Invasive.
Allergic fungal sinusitis (AFS) is commonly caused by Aspergillus, as well as Fusarium, Curvularia, and others. Patients often have associated asthma. The criteria include CT or MRI confirmation, a dark green or black material the consistency of peanut butter called “allergic mucin” which typically contain a few hyphae, no invasion, and no predisposing systemic disease. Charcot-Leyden crystals, which are breakdown products of eosinophiles are often found. Usually patients are found to be allergic to the fungus, although this is controversial. This disease is analogous to Allergic Bronchopulmonary Aspergilosis.
Fungus balls often involve the maxillary sinus and may present similarly to other causes of sinusitis including helitosis. In addition to radiological abnormalities, thick pus or a clay-like substance is found in the sinuses. There is no allergic mucin, but dense non-innervated hyphae are found. There is an inflammatory response in the mucosa. Upon looking into the sinus, the fungus ball can vary in size from sub-millimeter to the dimensions of the sinus. The fungus balls may have a greenish-black appearance. Removal of the fungus ball is the typical treatment.
Invasive sinusitis can progress rapidly, and typically necessitates surgery, often on an emergency basis and often requiring the intravenous administration of Amphotericin B as well. There have been some forms of invasive sinusitis, which can cause proptosis.
Fungal based sinusitis may be treated with topical fungicides alone or in combination with broad-spectrum antibiotics and corticosteroids. Usually, the fungicide/antibiotic are mixed with a saline irrigation solution and administered as part of irrigation therapy.
Accordingly, it is an object of the present invention to provide a composition and a method of treatment of bacterial and fungal sinusitis while minimizing or eliminating some or all of the complications associated with current antibiotic, anti inflammatory and/or antifungal therapies. It is another object of the present invention to provide a composition and method of treatment effective against chronic and acute sinusitis of either bacterial, fungal or allergic etymology.